Apr 2017 – Feb 2019 · 1 yr 10 mos

• Regulatory Strategy Development: Development and execution of regulatory plans and strategies for new products.
• Global Product Registrations: Critical review, co-ordination, execution, implementation and management of Technical Documentation for all ongoing and new regulatory submissions in compliance with applicable regulations and guidance documents for product registrations in global market [e. g. 510k, Technical Documentation (CTD/STED/CSDT) Pre-submission (Pre-IDE, Pre-ANDA, Q-Sub) briefing package, within designated timeframes, including timely responses to Agency questions.
• Regulatory/Medical Writing: Support and execution of Clinical Evaluation Reports as per MEDDEV Guidance Rev.4, Risk Management Report as per ISO 14971, Clinical study protocols, Investigator’s Brochure, PSUR.
• Interaction/Communications: Manage communications with regulatory agencies, notified bodies, customers, critical suppliers, consultants, testing labs for assigned project.
• Project Management: Manage effective coordination and implementation of design and development activities starting from Design Planning to design transfer to ensure timely submission of product registration applications to achieve business success.
• Team Management: Manage Regulatory professionals; mentoring, setting goals and objectives, providing coaching/guidance and evaluate performance. Lead process improvement within regulatory affairs.
• Resource Management: Manage and oversee resource allocation across projects. Ensure planning and proper organization of activities in line with the overall project plan and milestones.
• Inspections: Coordinate and participate in internal audits, external Regulatory agency inspections, supplier audits, and mock FDA audits.
• Product Life Cycle Management: Oversee and ensure that well-organized and auditable regulatory affairs files and regulatory database are maintained.
• Regulatory Intelligence
• Review of DHF Documents

Apr 2016 – Mar 2017 · 11 mos

Jan 2011 – Mar 2016 · 5 yrs 2 mos

Apr 2010 – Dec 2010 · 8 mos · India

• Type of Dosage forms Handled – Sterile Injectables (Liquid Vial, Lyophilized vial, Ophthalmic bottle)
• Peptides/Small Molecules: Eptifibatide, Octreotide, Bivalirudin, Zoledronic Acid, Olopatadine
• Peptides/Biosimilars: Pegfilgrastim, Somatropin, Teriparatide
• Assisted in writing & reviewing regulatory submission documents for CMC module.
• Ensured compliance of CMC Documentation with global regulatory standards (FDA, EMA, ICH).
• Led the cross-functional coordination efforts for EU MAA and US BLA & ANDA Projects, ensuring the timely availability of required CMC documentation for regulatory submissions.
• Performed comprehensive reviews of executed documents of exhibit batches (MFRs, BMRs, BPRs), stability data, Analytical method validation, container closure integrity to support regulatory filings.
• Prepared protocols and reports for critical processes including media fill validation, Sterilization process validation, cleaning validation, system and equipment Qualification, ensuring regulatory compliance with EU and US regulatory requirements.
• Authored and maintained SOPs, VMP, and SMF ensuring adherence to cGMP standards.

Aug 2009 – Mar 2010 · 7 mos · Ankleshwar

• Conducted detailed reviews of executed Batch manufacturing records (BMRs) and batch packaging records (BPRs), ensuring compliance with regulatory standards.
• Led IPQA (In - process Quality Assurance) activities during manufacturing of Sterile Injectables Dosage forms to ensure compliance with cGMP requirements.
• Authored and reviewed process validation, analytical method validation and equipment qualification protocols and Reports, ensuring alignment with regulatory expectations.